Red yeast rice players said they were scrutinising the ANSES statement and would contribute to the consultation.
ANSES said most of the health problems, dating back to 2009, were muscle and liver related.
“ANSES considers that use of food supplements containing red yeast rice may expose consumers – especially those who are particularly vulnerable due to genetic predispositions, pathologies, ongoing treatments, etc. – to health risks,” the agency said.
ANSES warned people taking statin-based medications, pregnant or breastfeeding women, children and adolescents, over 70s as well as people, “suffering from certain pathologies and people who consume large amounts of grapefruit”.
It highlighted the active constituent, monacolin K, which it said, “has the pharmacological characteristics of statins, meaning that it has the ability to inhibit an enzyme (HMG-CoA reductase) involved in the cholesterol synthesis pathway.”
Monacolin K trades in the pharma space as ‘lovastatin’ in the US, Canada, Germany, Austria, Spain, Portugal and Greece.
It does not have approval in France.
ANSES opined: “It therefore appears at the end of this assessment that, under current conditions the use of food supplements containing red yeast rice, and those containing monacolins in particular, can expose consumers - especially those particularly vulnerable due to genetic predispositions, pathologies or ongoing treatments, etc. - to a health risk.”
“This health risk may be higher if their consumption is not accompanied by any medical advice or supervision.”
The consultation can be found here.